2 2015 Board of Regents of the University of Wisconsin System All rights reserved. For additional copies: Publications Office La Follette School of Public Affairs 1225 Observatory Drive, Madison, WI The Robert M. La Follette School of Public Affairs is a teaching and research department of the University of Wisconsin Madison. The school takes no stand on policy issues; opinions expressed in these pages reflect the views of the authors.

6 Foreword This report is the result of collaboration between the Robert M. La Follette School of Public Affairs at the University of Wisconsin-Madison and the Wisconsin Legislative Council, a state agency. The objective of this project is to provide graduate students at the La Follette School the opportunity to improve their policy analysis skills while contributing to the capacity of partner organizations. The La Follette School provides students with a rigorous two-year graduate program leading to a master s degree in public affairs. Students study policy analysis and public management, as well as concentrating study in at least one policy area. The authors of this report are all in their final semester of their degree program and are enrolled in the Public Affairs 869 Workshop in Public Affairs at the University of Wisconsin Madison. Although studying policy analysis is important, there is no substitute for engaging actively in applied policy analysis as a means of developing policy analysis skills. The Public Affairs 869 Workshop gives graduate students that opportunity. The nonpartisan Wisconsin Legislative Council provides support to legislators and committees of the Wisconsin Legislature by convening study committees and drafting special reports. The issue of opioid addiction and treatment is of growing concern nationally and in Wisconsin. The Legislative Council is attempting to better understand treatment alternatives, and how legislative and regulatory actions might enhance public access to opioid addiction treatment for patients in the greatest need of help. This report summarizes current treatment access using public and administrative data and then uses this analysis to inform a range of policy options for expanding access to treatment. Given the harm imposed on families and communities by opioid addiction, this issue is critical for policymakers to better understand. I am grateful to the Legislative Council for partnering with the La Follette School on this project. The staff of the council have been generous with their support for the students, and the students have collectively contributed hundreds of hours to this report. The La Follette School is grateful for their efforts and hopes that this report proves valuable for the development of policies that can improve the welfare of families and communities struggling with the hardships of addiction. J. Michael Collins Professor of Public Affairs May 2015 Madison, Wisconsin vi

7 Acknowledgments Our team owes a debt of gratitude to everyone who assisted us during the production of this report. We would like to thank: Representative John Nygren and Jennifer Malcore, without whom this endeavor would not have been possible Mary Matthias and Melissa Schmidt at the Wisconsin Legislative Council for soliciting this report and advising us throughout the project Louis Oppor and others at the Wisconsin Department of Health Services for granting us access to their data and expertise Dr. Aleksandra Zgierska and Kevin Meighan for providing their expert advice Karen Faster for helping this project reach its full potential Professors Michael Collins and Don Moynihan for their guidance and mentorship, which have immensely enriched our educational experience vii

8 Executive Summary Drug abuse is now the leading cause of accidental death in the United States. An alarming number of these deaths can be attributed to a group of drugs known as opioids. Opioids include the illicit drug heroin in addition to pain-relieving drugs such as hydrocodone, oxycodone, morphine, methadone, and buprenorphine. In Wisconsin alone, opioid-related deaths nearly doubled from 2005 to 2012, indicating that opioid abuse is a serious threat to the well-being of Wisconsin residents. Addressing opioid abuse and addiction requires a multifaceted approach. Ensuring accessible and effective opioid addiction treatment is a key part of any strategic plan to address the problem. This report examines several aspects of opioid treatment necessary for designing policy interventions to combat the growing danger posed by opioid addiction. Wisconsin must supply opioid addiction treatment services that are accessible and clinically effective. Medication-Assisted Therapy (MAT) is the treatment process officially recommended by the Federal Government. However, individuals seeking opioid addiction treatment may experience difficulty in obtaining MAT due to geographic limitations and lifestyle impact. MAT requires pharmacological and counseling therapies, and a significant investment of time and determination on the parts of the individual with the opioid addiction and the physicians and therapists who must collaborate to make recovery a reality. Individuals can obtain MAT from a variety of sources. Many individuals seek treatment from state and federally certified treatment centers known as opioid treatment programs (OTPs), commonly known as methadone clinics. Others obtain services from hospitals and mental health care centers, but each treatment setting comes with unique strengths and limitations. As addiction is a disease for which there is no cure, treatment focuses on managing the negative effects of addiction. This report examines the current supply of opioid addiction treatment services in Wisconsin and identifies barriers to accessing treatment services. An individual seeking treatment for opioid addiction ideally will progress through a four-phase treatment process. First, treatment providers assess the individual and diagnose their condition. Next, the individual undergo detoxification with the assistance of treatment opioids like methadone and buprenorphine or other medications that ease the side effects of withdrawal. The patient begins MAT with or after detoxification. This phase can last years or, in extreme cases, a lifetime. When the patient is physically and psychologically ready, s/he begins tapering off the treatment drugs and shifting to continuing care. The continuing care phase involves planning for lifetime addiction management and therapeutic support. A complex web of state and federal regulation governs OTPs. In addition to federal regulations, Wisconsin has its own regulations that affect patient access to MAT and create administrative burdens. Some of these regulations impair access by requiring individuals to reside within a specific distance of the facility and by setting directives that govern where and from whom an individual seeking treatment may obtain these services. Regulation is important for ensuring ethical behavior and the delivery of clinically effective services, but some of Wisconsin s viii

9 regulations needlessly restrict the delivery of clinically effective and accessible treatment services. This report examines five policy options that can increase access to treatment services and ensure clinically effective treatment. For example, Wisconsin regulates the treatment of opioid dependence more stringently than the federal government requires. Creating a more favorable regulatory environment could increase accessibility to treatment for many of those in need. The State could add training to the medical school curriculum to increase the number of physicians qualified to prescribe treatment drugs, or it could create comprehensive care facilities that utilize MAT. Wisconsin could also increase access to MAT by expanding a pilot program of county collaboration. This program encourages counties to collaborate and share services. Finally, the State could begin collecting more data specific to opioid use. Data regarding this issue are often missing, unreliable, or limited. Improving data collection and reporting would help the State quantify unmet need and better develop programs to address opioid abuse. This analysis does not judge which policy option is best. Instead, the options are individually evaluated against criteria that include access, accountability, implementation cost, and ability to address gaps in treatment that could lead to relapse or treatment failure. None of the policy options provided are mutually exclusive; this flexibility allows for policy-maker discretion in determining the best approach for addressing opioid addiction treatment needs for Wisconsinites. ix

10 Introduction Drug overdose is reaching epidemic proportions in the United States, having surpassed traffic accidents as the leading cause of injury death (Office of Food and Drug Administration Commissioner Margaret A. Hamburg 2014). A specific group of drugs known as opioids are one of the primary causes of overdose death. Opioids include the illicit drug heroin and pain relieving drugs like hydrocodone, oxycodone, morphine, methadone, and buprenorphine. States across the nation are looking for solutions to stem the surge of opioid abuse. Statistical data from the State of Wisconsin Department of Health Services (DHS) indicates that the opioid abuse epidemic has hit home. Since 2005, the number of deaths attributable to opioid use in Wisconsin has nearly doubled (see Figure 1; more data are available in Appendix A: Data). Accordingly, Wisconsin needs to take action to address this issue, starting with improving access to clinically appropriate treatment services. 600 Figure 1. Wisconsin Opioid-Related Deaths, Number of Deaths Year Source: Wisconsin Death Records; Department of Health Services, Division of Public Health, Office of Health Informatics Note: Opioid deaths include diagnosis codes indicating the underlying cause of death due to opioid use. Increasing access to treatment begins with a comprehensive understanding of the characteristics and locations of appropriate treatment options. We have reviewed clinical recommendations, examined barriers to accessing treatment, and evaluated the supply of and demand for treatment in Wisconsin. Our sources include contemporary research, distinguished addiction treatment experts, and data from state and federal agencies. Scope Our report focuses on opioid addiction treatment as a voluntary choice, even though all aspects of opioid addiction treatment affect involuntarily treated individuals as well. For example, the 1

11 phases of the clinically recommended treatment process are the same for both classifications of opioid dependent. 1 Jails, prisons, hospitals, and mental health care centers all may need to treat individuals who are involuntarily experiencing opioid withdrawal, thereby beginning the treatment process. Many communities have expressed concern that they are ill-equipped to provide detoxification services and continuing care in appropriate and safe settings. Our goal is to provide communities with the clinical and availability information they need to develop and refine opioid addiction treatment practices. Other populations in the state may have specific treatment needs that are not addressed in this report. For example, incarcerated dependents, groups with specific cultural needs, and youth may require unique treatment services. Many of our policy options will have positive overall effects for these groups, but more research is needed to address whether there are specific treatment needs for these groups and others. Our research is also limited regarding the evaluation of costs of treatment for dependents. The number of treatment provider options and phases in the treatment process preclude a one-size fits all cost analysis. To determine cost barriers in greater detail, the scope of this analysis would have to be limited to one payment system and a standardized treatment plan. In reality, though, every treatment sequence is unique from the reason for treatment to the medications used to the duration of treatment. Understanding and Treating Addiction Providing treatment requires basic knowledge about addiction and the challenges dependents face. First, addiction is a disease with no cure. Second, a disease with no cure requires a lifelong commitment to recovery and the prevention of relapse. The recovery process for opioid addiction remains the same whether or not the problem opioid 2 is illicit (such as heroin) or legally prescribed for pain relief or other therapeutic purposes. Opioid addiction recovery has multiple phases with the following goals and processes: Detoxify from the problem opioid, with our without the aid of a treatment opioid. 3 Begin recovery. This phase includes treatment opioid adjustment, replacing unhealthy behaviors with healthy behaviors (often through counseling or group therapy), repairing relationships, learning to recognize and avoid triggers, developing skills to prevent relapse, managing at-home usage of treatment opioids, and random drug testing. Stay in recovery. This phase requires maintaining a routine schedule, attending follow-up care with physicians and counselors, continuing to avoid triggers, and random drug testing. Live free of addiction. This phase involves a continued commitment to healthy behaviors and routines, regularly scheduled visits with the treatment provider, and participation in counseling (SAMHSA 2014a). 1 For purposes of this paper, opioid dependent refers to any individual suffering from opioid addiction. 2 A problem opioid is the specific drug or drugs to which the individual is addicted. 3 Treatment opioids include methadone and buprenorphine. 2

12 The lifelong recovery process requires a comprehensive treatment model. Our research indicates that Medication-Assisted Therapy (MAT) is the preferred clinical model for successfully treating addiction. On March 26, 2015, the U.S. Department of Health and Human Services announced a Federal Opioid Initiative that includes three strategies to address opioid abuse and calls for the expansion of MAT as the preferred treatment modality. The recommendation to utilize MAT is based on rigorous research that has found MAT to provide the greatest likelihood of clinically meaningful outcomes for dependents (ASPE 2015). The Substance Abuse and Mental Health Service Administration (SAMHSA) likewise views MAT as the most effective method for treating opioid dependence (2005). Treatment programs that do not utilize treatment drugs 4 are often associated with relapse (NDCP 2012). Relapse can be dangerous for the patient because opioid tolerance fades very quickly, and even one relapse can be life-threatening. MAT thus favors a phased approach that does not always emphasize complete detoxification (NDCP 2012). Opioid Addiction Treatment in Wisconsin MAT is a comprehensive opioid addiction treatment model that provides treatment opioids and counseling services. Treatment opioids and counseling services as part of MAT are generally administered by an opioid treatment program (OTP), which is any setting in which both treatment opioids and counseling services are offered. 5 Designation as an OTP requires state and federal certification. DHS lists 15 OTPs in Wisconsin as of 2014, shown in Figure 2. According to the Wisconsin Opioid Treatment Program Patient Reference Handbook (2014), all patients must meet a set of five criteria to be accepted into an OTP. The basis of these criteria is a combination of state and federal regulations. The criteria are as follows: 1. Be 18 years of age or older 2. Must meet the substance dependence criteria in the DSM-IV-TR 6 3. Must be medically able to tolerate treatment 4. Must possess a State of Wisconsin issued photo ID to prove Wisconsin residency 5. Must reside within 50 miles of the treatment clinic There are many treatment settings outside of certified OTPs. The treatment process and services offered might vary from what is offered at an OTP because treatment service providers include non-certified clinical settings, physicians licensed to dispense treatment opioids, and counseling centers. Some of these providers may offer MAT, but they also might only offer singular components of opioid addiction treatment, such as treatment opioids without counseling. Noncertified providers are an important part of the opioid addiction treatment landscape because they are often more accessible than OTPs. 4 Treatment drugs include treatment opioids and also include non-opioids drugs such as naltrexone. 5 OTPs are often more commonly known as methadone clinics, but can include other clinical settings. The defining feature of an OTP is program certification. 6 The DSM-IV-TR is the manual used by U.S. mental health professionals for classification and treatment recommendations for mental disorders. 3

13 Figure 2. Map of OTPs with Methadone Certification Treatment providers may be in private hospitals, substance abuse clinics, and county public health departments. Private hospitals provide a wide array of services, including inpatient detoxification and rehabilitation, residential services, hospitalization, intensive outpatient programming, and recovery groups. Hospitals also provide emergency room services to stabilize dependents. Substance abuse clinics are private or non-profit clinics that may be associated with hospitals, churches, or other non-profit organizations. They specialize in providing mental health and substance abuse services. County services may provide case management, day treatment services, detoxification, outpatient services, and residential treatment. As of April 11, 2015, the SAMHSA Physician and Treatment Program Locator listed 60 noncertified treatment programs and 187 physicians licensed to dispense the opioid addiction treatment buprenorphine in Wisconsin, shown in Figure 3. These programs and physicians can dispense treatment opioids, and they make up the group of non-certified providers in Wisconsin who could offer MAT. Six counties collaborate to provide regional services through the Mental Health and Substance Abuse Collaborative Pilot sponsored by DHS. In this pilot, a lead county partners with two nearby counties to provide approximately 30 mental health and substance abuse services (DHS 2015). These services are listed in Appendix B: County Pilot Benefits. 4

14 Figure 3. Map of Buprenorphine Authorized Programs and Physicians Not all Wisconsin residents have equal access to opioid addiction treatment services. Geographic proximity to an OTP or provider, inadequate number of qualified treatment providers, limited support for ensuring transition between treatment phases, and the inability to integrate treatment with family and employment commitments all create access issues for individuals seeking opioid addiction treatment. Providers themselves can be limited by state and federal regulation, training requirements, structural support at the clinic and community level, and personal attitudes about opioid-addicted patients (Woods and Josephs 2012). Problem Definition In Wisconsin, there is an unmet need for opioid addiction treatment. As discussed, Wisconsinites face access barriers due to geography and lack of providers. Several gaps in the treatment process may allow dependents to relapse or abandon treatment. Finally, due to the rapid increase in opioid addiction, supply has not kept up with estimated demand. Physical Access Barriers Physical access to treatment, or the ability to enter a treatment facility and obtain treatment, is essential to beginning the opioid addiction recovery process. As noted, Wisconsin has a variety of opioid addiction treatment services available, but not every geographic region is home to an OTP. Limited treatment availability in areas of the state is exacerbated by regulatory 5

15 requirements that limit distance between the patient and an OTP or provider as well as restrictions on take-home options for treatment opioids. As seen in Figures 2 and 3 above, particular areas of the state lack an OTP or sufficient buprenorphine certified physicians. These areas include the northwest, near Bayfield and Ashland counties, the northeast, including Florence, Forest, and Marinette counties; the middle, including Juneau and Adams counties; and finally the southwest, around Grant County. These areas are again highlighted in Figure 4, which shows the estimated need in each county overlaid with the 15 OTPs and all physicians certified to prescribe buprenorphine. Based on this map, the northeast region of Florence, Forest, and Marinette counties represents a high estimated need area that lacks treatment providers. In other words, residents of this area are unable to access treatment simply due to where they live. Physical access to an OTP or provider is hard to obtain for the dependent seeking treatment because they need 1) available, affordable, and reliable transportation; 2) flexibility in employment and family schedules that make travel possible; and 3) a strong will to frequently travel long distances to receive treatment. Figure 4. Map of Estimated Need in Comparison with Services Provided 6

16 Treatment Gaps Once a dependent is able to physically access treatment, he or she is vulnerable to relapse when there is a break in the treatment process. There are three specific points of vulnerability: initial access to treatment services, transfer between phases of the treatment process, and continuing recovery care. Initial access to treatment can be inhibited if an individual attempts to secure treatment at a facility or through a doctor, or the individual is waitlisted or turned away due to lack of space. Figures 5 and 6 show information culled from county programs, which represent only a small subset of treatment programs available to the patient. However, data from privately held facilities on this topic is unavailable. Fifteen of 72 counties reported having waiting lists for county programs in 2012, and, of these 15 counties, six reported having turned people away. One county reported turning people away but did not report waitlist data. Counties turning people away from service or waitlisting individuals indicates a gap in treatment. We do not know the extent of the problem in private clinics or with buprenorphine doctors at this time. Figure 5. Map of Number of People Waitlisted from County Programs,

17 Figure 6. Map of Number of People Turned Away from County Programs, 2012 The transition between services, such as from pharmacological treatment to counseling, marks a second potential gap in addiction treatment. While no data on the magnitude of this gap exist, physicians have anecdotally remarked that patients interested in counseling are simply given a business card and that patients rarely follow up on the referral. The burden is on the patient to navigate the admission process for an OTP or to find and schedule individual appointments with a therapist who is unknown to them. This gap is of particular concern when therapy is administered outside of an OTP. Even if an individual receives treatment medication, their treatment may fail because the drug is not supplemented with the necessary counseling. Connecting patients receiving treatment drugs to appropriate counseling is essential to their longterm recovery. Finally, the patient may have difficulty entering the long-term maintenance phase of treatment if a solid treatment plan is not in place and treatment resources are unavailable or inconvenient to obtain. Again, no specific data for Wisconsin exists on failure rates at this point in treatment, but as we will discuss, the retention rates of various treatment drugs differ. Methadone has been shown to have the highest retention rate, which could, in part, be due to the well-regulated treatment plans of patients in OTPs that dispense this drug. Buprenorphine, while also highly effective, has lower retention rates. This disparity could stem from the lack of connection between medication and counseling, which can result from receiving the drug outside of a comprehensive clinic setting. If a patient encounters any of the three treatment gaps, the recovery process may be jeopardized. Access, guided transitions, and long-term follow-up care must be available to ensure a successful 8

18 recovery. OTPs and providers in Wisconsin must be administered in ways that address access barriers, minimize the possibility for relapse stemming from treatment gaps, and utilize the best practice model of MAT. Estimating Demand for Treatment Programs To establish the desire to access treatment of dependents within the state, we estimate the demand for treatment programs across Wisconsin. Unmet need for opioid treatment services can be viewed as a supply and demand model where patients demand services and OTPs and providers supply services. Opioid-related deaths and survey data from the DHS provide some insight into potential demand for treatment throughout the state. However, there is no reliable way to estimate motivation for treatment; instead, we estimate the total number of individuals who likely have an opioid addiction at this time. See the Appendix A: Data for supplemental data on arrests, hospitalizations, and emergency room visits, which are also indicators of demand. In 2005, Wisconsin had 266 opioid-related deaths, meaning that about one in 20,000 Wisconsinites died from opioid-related causes. By 2012, the number of opioid-related deaths had steadily increased to 485, representing about one in 12,000 Wisconsinite deaths, as outlined in Table 1. Opioid-related deaths varied significantly by county, ranging from zero deaths to 146 deaths, as shown in Figure 7. Similarly, opioid-related hospitalizations, emergency room visits, Medicaid admissions, and county-reported admissions varied significantly across the state. Based on these data, Wisconsin s opioid problem is growing. Table 1. Wisconsin Opioid-Related Deaths, Total Wisconsin Deaths Mean County Deaths Wisconsin per Capita Deaths Mean County per Capita Deaths Source: Wisconsin Death Records; Department of Health Services, Division of Public Health, Office of Health Informatics Note: Opioid deaths include ICD-9 diagnosis codes indicating that the underlying cause of death was due to opiate use; total opiate deaths is derived by summing the number of opioid deaths in each Wisconsin county; mean values are derived from opioid death values for each Wisconsin county. Further estimating client demand for treatment services is challenging given data limitations. Based on available data and surveys, need for treatment services can be established by estimating the number of dependents and applying observed proportions of those who seek treatment. A full description of the calculation methodology can be found in the Appendix A: Data. Figure 8 displays these calculations on a per-capita basis, showing both the regional disparity in estimated demand for treatment services and the overall demand for treatment programs. 9

20 Alternatively, the National Survey on Drug Use and Health shows that 4.5 percent of Wisconsin adults have recently used opioids for non-medical purposes. Applying this survey result to Wisconsin s 2013 adult population yields an estimated demand as high as 200,000 or 350 per 10,000 population (DHS 2013b). Given the data limitations, these two survey-derived estimates of demand in Wisconsin may be the best possible way to estimate need in the state. Estimating demand demonstrates the potential for a large unmet need, but the lack of data on providers hinders quantifying the supply of treatment services. The mere geographic locations of treatment providers do not indicate whether adequate capacity exists. Overall, locations of OTPs and other treatment providers offer some indication of geographic access across Wisconsin, just as the aforementioned waitlist and turned away data provide some insight into capacity. More information is available in Appendix A: Data. The Treatment Process Since the discovery of replacement opioids some 50 years ago, providers and researchers have been honing the treatment process for opioid addiction. While the phases of treatment outlined below are generally accepted, questions remain about best treatment practices. For example, we do not know precisely how long therapy should last. Likewise, we do not yet know when treatment can be safely discontinued, nor do we know the most effective way to handle individuals who exit treatment prematurely. Familiarity with the treatment process is necessary both to recognize the flaws inherent in the system and to understand potential solutions for addressing those shortcomings. There are four phases in the treatment process for opioid addiction. Treatment begins with assessment and diagnosis, continues through opioid detoxification and MAT, and closes with continuing care management. Figure 9 illustrates the treatment process from the perspective of the individual seeking treatment. Figure 9. Treatment Process Map Source: Adapted from ASAM

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